Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03048110
Other study ID # 17726
Secondary ID 2016-004469-20
Status Completed
Phase Phase 1
First received
Last updated
Start date February 15, 2017
Est. completion date July 19, 2017

Study information

Verified date July 2018
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluate the effect of a probe CYP3A4 inhibitor and inducer on the pharmacokinetics of BAY1841788 (ODM-201)


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date July 19, 2017
Est. primary completion date May 4, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria:

- Healthy subject - as determined by the investigator or medically qualified designee based on medical evaluations including medical history, physical examination, laboratory tests and cardiac monitoring.

- Gender: Male.

- Age: 45 to 65 years (inclusive) at the screening visit.

- Race: White.

- Body mass index (BMI): =18.0 and =30 kg/m^2.

- Agree to use condoms as an effective contraception barrier method and refrain from sperm donation during the whole study (starting after informed consent) and for 3 months after the end of treatment with ODM-201. In addition, participants must agree to utilize a second reliable method of contraception simultaneously. The second method which has to be used by a female partner of childbearing potential can be one of the following methods: diaphragm or cervical cap with spermicide or intra-uterine device or hormone-based contraception.

- Results of alcohol tests are negative at screening and on Study Day -1.

Exclusion Criteria:

- Medical and surgical history

- Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (for example seizures) or other organs (e.g. diabetes mellitus).

Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.

- Febrile illness within 1 week before the first study drug administration.

- A medical history of risk factors for Torsades de Pointes (e.g. family history of Long QT Syndrome) or other arrhythmias.

- Known severe allergies, non-allergic drug reactions, or (multiple) drug allergies (excluding untreated, asymptomatic seasonal allergies like non-severe hay fever during the time of study conduct).

- Known history of hypersensitivity (or known allergic reaction) to itraconazole, rifampicin or ODM-201.

- Relevant hepatic disorders like cholestasis, disturbances of bilirubin metabolism, any progressive liver disease.

- Relevant renal disorders like recurrent glomerulonephritis, renal injury, and renal insufficiency. However, a history of a single episode of uncomplicated nephrolithiasis will not prevent participation.

- Subjects with porphyria.

- Subjects with diagnosed malignancy within the past 5 years except for cured skin basal carcinoma.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BAY1841788 (ODM-201)
In Period 1, 600 mg single dose administered as 2x300 mg tablets on Study Day 1, In Period 2, 600 mg single dose administered as 2x300 mg tablets on Study Day 5, In Period 3, 600 mg single dose administered as 2x300 mg tablets at Study Day 8.
Itraconazole
200 mg twice daily (BID) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Day 1, 200 mg once daily (QD) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Days 2 to 7.
Rifampicin
600 mg QD administered as 1 x 600 mg tablet per dose in treatment period 3 on Study Days 1 to 10.

Locations

Country Name City State
Germany CRS Clinical Research Services Berlin GmbH Berlin

Sponsors (2)

Lead Sponsor Collaborator
Bayer Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of Darolutamide in Plasma After Single Dose Administration of Darolutamide Area under the concentration versus time curve from time zero to 72 hours of Darolutamide after single dose administration in plasma were measured. Pre dose to 72 hours post dose of darolutamide
Primary Maximum Observed Concentration (Cmax) of Darolutamide in Plasma After Single Dose Administration of Darolutamide Maximum observed concentration after single dose administration in plasma were measured. Pre dose up to 72 hours post dose of darolutamide
Primary Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of (S,R)-Darolutamide in Plasma After Single Dose Administration of Darolutamide Area under the concentration versus time curve from time zero to 72 hours of (S,R)-Darolutamide in plasma after single dose administration of Darolutamide were measured. Pre dose up to 72 hours post dose of darolutamide
Primary Maximum Observed Concentration (Cmax) of (S,R)-Darolutamide in Plasma After Single Dose Administration of Darolutamide Maximum observed concentration of (S,R)-darolutamide in plasma after single dose administration of darolutamide were measured. Pre dose up to 72 hours post dose of darolutamide
Primary Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of (S,S)-Darolutamide in Plasma After Single Dose Administration of Darolutamide Area under the concentration versus time curve from time zero to 72 hours of (S,S)-darolutamide in plasma after single dose administration of darolutamide were measured. Pre dose up to 72 hours post dose of darolutamide
Primary Maximum Observed Concentration (Cmax) of (S,S)-Darolutamide in Plasma After Single Dose Administration of Darolutamide Maximum observed concentration of (S,S)-darolutamide in plasma after single dose administration of darolutamide were measured. Pre dose up to 72 hours post dose of darolutamide
Primary Area Under the Concentration Versus Time Curve From Time Zero to 72 Hours (AUC[0-72h]) of Keto-Darolutamide in Plasma After Single Dose Administration of Darolutamide Area under the concentration versus time curve from time zero to 72 hours (AUC[0-72h]) of keto-Darolutamide in plasma after single dose administration of darolutamide were measured. Pre dose up to 72 hours post dose of darolutamide
Primary Maximum Observed Concentration (Cmax) of Keto-Darolutamide in Plasma After Single Dose Administration of Darolutamide Maximum observed concentration of keto-darolutamide in plasma after single dose administration of darolutamide were measured. Pre dose up to 72 hours post dose of darolutamide
Secondary Number of Subjects With Study Drug-Related Treatment Emergent Adverse Events (TEAEs) An adverse event (AE) was any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. AEs that started or worsened after first administration of study medication up to 30 days after end of treatment with study medication were considered to be treatment-emergent (TE). AEs that occurred on study drug administration were termed as study drug related adverse events. From start of study drug administration up to 30 days after last dose of study medication
See also
  Status Clinical Trial Phase
Completed NCT05544786 - Relative Bioavailability Study of Nirmatrelvir/Ritonavir Oral Powder Relative to the Commercial Tablets and Estimation of the Effect of Food on Bioavailability of the Nirmatrelvir/Ritonavir Oral Powder in Healthy Participants. Phase 1
Completed NCT04744233 - Bioavailability of Carotenoids From Orange Juice in a Cross-over Study in Healthy Subjects. N/A
Completed NCT05561075 - Oral Bioavailability of Pterostilbene Cocrystal Compared to Its Free Form (BIOPTERO) N/A
Completed NCT03873909 - Bioavailability of Carotenoids Present in Mamey Sapote (Pouteria Sapota (Jacq.) H. E. Moore & Stearn) Fruit N/A
Completed NCT03353857 - Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam Phase 1
Completed NCT05121506 - A Study to Investigate the Bioavailability and Skin Absorption of CBD and THC From GT4 Technology in Healthy Adults Phase 1
Completed NCT01267201 - A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form Phase 1
Completed NCT02538393 - Relative Bioavailability of Sorafenib Tablet for Oral Suspension Phase 1
Completed NCT05116982 - Effect of Three Silicon Based Food Supplements on the Urinary Excretion of Aluminum and Other Metals (SILIAL) N/A
Completed NCT04207372 - Protein Digestibility of Whey and Zein. N/A
Completed NCT01853800 - Relative Bioavailability of Oral Suspension of Rivaroxaban Compared to Standard Tablet Phase 1
Completed NCT00714584 - Pharmacokinetics of Naltrexone Following Intravenous and Oral Routes of Administration in Healthy Volunteers Phase 1
Completed NCT04876261 - Bioavailability of Hydroxytyrosol From Olive Watery Extract Supplements N/A
Completed NCT03886597 - Nutritional Intervention With Table Olives in Healthy Volunteers Phase 1/Phase 2
Completed NCT06289140 - Oral Bioavailability of a New Formulation of Pterostilbene Cocrystal in Comparison With Its Free Form (BIOPTERO2) N/A
Completed NCT05439408 - Comparative Bioavailability of XS004 (Dasatinib) Formulation G and SPRYCEL® (Dasatinib) in Healthy, Adult Subjects Under Fasting Conditions Phase 1
Completed NCT03951025 - Study of the Bioavailability of a Food Supplement Rich in Melatonin Administered Sublingually and Orally (MELATONIN) Phase 2
Completed NCT03984916 - Study of the Bioavailability of Three Hesperidin Extracts. N/A
Completed NCT02966704 - Stable Isotope Method to Assess Dietary Protein Quality N/A
Completed NCT02847117 - Bioavailability of the Microconstituents of Natural Chios Mastiha in Healthy Adults. N/A